How does it work?

Betaferon injection contains the active ingredient interferonbeta-1b, which is a type of medicine called an immunomodulator.

Interferons are a family of small protein molecules that areproduced by cells in response to viral infections or various synthetic andbiological inducers. Three major classes of interferons have been identified:alfa, beta and gamma. They work in a complicated way that is not fullyunderstood, but are thought to boost the immune system, causing it to attackinfected or abnormal cells.

Interferon beta is used to treat multiple sclerosis (MS). Insome people, this disease follows a course of relapse and remission, wheresymptoms worsen for a while, then improve before worsening again. It is thesepeople who can benefit from interferon beta. The medicine helps to reduce thefrequency and severity of the relapses. It is not fully understood howinterferon beta works in MS, because the disease and its cause are not fullyunderstood.

Betaferon is given by injection under the skin (subcutaneously)every other day.

Interferon beta is not effective in all people with multiplesclerosis and, because it can have significant side effects, it is recommendedthat all patients are assessed by a neurologist before starting treatment.

It is not known how long treatment should be continued for.However, it is recommended that patients should be clinically eva luated aftertwo years of treatment. You may develop neutralising antibodies to thismedicine that make it less effective. The medicine should be stopped if your MSbecomes progressively worse despite treatment.

What is it used for?

• Relapsing/remitting multiple sclerosis (characterised by at least two relapses over the previous two years, in people who are able to walk unaided).
• Secondary progressive multiple sclerosis in people with active disease evidenced by relapses.
• Treatment of patients who have experienced a single multiple sclerosis-like attack, severe enough to need treatment with intravenous corticosteroids, if alternative diagnoses have been excluded and they are at high risk of developing clinically definite multiple sclerosis.

Warning!

• Treatment with this medicine should only be started by a specialist in multiple sclerosis.
• Carefully follow the instructions provided with your injections. Some people have experienced skin reactions at the injection site that can result in scarring. To minimise the risk of this, a different injection site should be used each time you inject. Using an autoinjector can also reduce the risk of skin reactions. Ask your doctor about this. If you experience any break in your skin, which may be associated with swelling or drainage of fluid from the injection site, you should consult your doctor before administering any more injections. If you get more than one such skin lesion you may need to stop treatment until they have healed.
• This medicine can cause flu-like symptoms such as aches and pains, fever, chills, sweating or headache. These tend to be worse at the start of treatment and improve with continued treatment. You may want to take a medicine to reduce these symptoms, for example, aspirin or ibuprofen. Ask your doctor or pharmacist for advice.
• This medicine has been associated with depression that can occur at any time during treatment. You should discuss this with your doctor before starting treatment. It is important to talk to your doctor immediately if you have any distressing thoughts or feelings, thoughts about suicide or self-harm, mood changes, or any other unusual change in behaviour while having treatment with this medicine. It may be necessary to stop treatment.
• This medicine has rarely been associated with liver problems. Symptoms that could indicate liver problems include unexplained itching, nausea and vomiting, abdominal pain; loss of appetite or flu-like symptoms; yellowing of the skin or eyes (jaundice); or unusually dark urine. Tell your doctor if you experience any of these symptoms during treatment with this medicine.
• This medicine may rarely decrease the number of blood cells in your blood. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• During treatment with this medicine you should have regular blood tests to monitor your liver function and the levels of blood cells in your blood.
• Betaferon contains human albumin and hence carries a potential risk for transmission of viral diseases. A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.

Use with caution in

• Rare disorder of the immune system in which abnormal proteins are found in the blood (monoclonal gammopathy)
• History of depression
• History of seizure disorders, eg due to brain injury or epilepsy
• Heart disease, such as angina, heart failure or irregular heartbeats (arrhythmias)
• History of an overactive or underactive thyroid gland
• Decreased blood cell production by the bone marrow, causing lower than normal levels of blood cells in the blood
• Severely decreased kidney function
• Severely decreased liver function
• History of liver disease
• History of alcohol abuse
• History of inflammation of the pancreas (pancreatitis)
• History of raised levels of fats called triglycerides in the blood.

Not to be used in

• Children and adolescents under 18 years of age
• People with severe depression or thoughts of suicide
• Uncontrolled epilepsy
• Untreated liver disease
• Pregnancy
• Breastfeeding.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine should not be used during pregnancy, because it may be harmful to the developing foetus and may increase the risk of miscarriage. Women who could get pregnant should use an effective method of contraception to prevent pregnancy while having treatment with this medicine. If you get pregnant during treatment or want to try for a baby you should consult your doctor immediately for medical advice.
• It is not known if this medicine passes into breast milk. The manufacturer states that it should not be used during breastfeeding. Alternatively, breastfeeding can be stopped. This decision will depend on the importance of the medicine to the mother. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

• Flu-like symptoms such as aches and pains, fever, chills, sweating and headache. These tend to be worse at the start of treatment and improve with continued treatment.
• Injection site reactions such as pain, redness, swelling, skin discolouration or breakdown of cells (necrosis)
• Disturbance in the normal numbers of blood cells in the blood
• Temporary weakness or rigidity of muscles after the injection that may prevent voluntary movements
• Pain in the muscles or back
• Depression
• Dizziness
• Difficulty in sleeping (insomnia)
• Gut disturbances, such as diarrhoea, constipation, nausea, vomiting, abdominal pain
• Rash or itching
• Hair loss (alopecia)
• Increased blood pressure
• Chest pain
• Loss of appetite
• Heavy or irregular menstrual bleeding
• Under or overactive thyroid
• Anxiety
• Confusion
• Seizures (convulsions)
• Inflammation of the liver (hepatitis)

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whileusing this one, to ensure that thecombination is safe.

No formal interaction studies have been conducted with thismedicine.

The manufacturer states that using this medicine in combinationwith other immunomodulating drugs, for example glatiramer, is not recommendeddue to lack of clinical experience.

There may be an increased risk of side effects on the liver orblood cells if other medicines that can affect the liver or blood cells areused in combination with this one.

This medicine may increase the blood level of the followingmedicines:

• antiepileptic medicines
• certain antidepressants
• zidovudine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain interferon beta-1b.

Avonex andRebif contain interferonbeta-1a.